Drug Development

Merck, Pfizer line up a big FDA decision on a blockbuster hopeful, staring down some major league competition

Two Big Pharma collaborators — Merck and Pfizer — have moved their SGLT2 diabetes drug hopeful ertugliflozin into the hands of regulators on both sides of the Atlantic.

Sam Engel, Merck

Armed with positive pivotal data, Merck and Pfizer are up for three PDUFA dates in December now: Monotherapy, a combo with bestselling diabetes drug Januvia and another combination with longtime diabetes standard metformin. The same trio of applications is also now under review in Europe.

Said Sam Engel, MD, associate vice president, Merck clinical research, diabetes and endocrinology: “If approved, we believe ertugliflozin will be an important option for many patients and a welcome addition to our already strong type 2 diabetes portfolio, with our DPP-4 inhibitor Januvia as the foundation.”

The magic number for A1C is 7.0%, which tells patients that the disease is being well managed and under control. And in the two drug arms for the pharma giants’ pivotal data, 32.1% and 39.9% of patients cleared that bar—compared to a less than stellar 17% of the placebo arm. Investigators also tracked a relevant 4.4 and 3.7 pound placebo-adjusted weight loss for their drugs. And there were significantly improved levels of fasting plasma glucose.

If they win an approval, the Merck/Pfizer team will face major league SGLT2 competition. Eli Lilly’s Jardiance has been in the spotlight with a huge cardio outcomes study in its favor. And J&J’s Invokana hit the market close to four years ago as the pioneering new drug in the class.

Not willing to play second fiddle to Jardiance, Merck and Pfizer are well into their own big cardio outcomes study, VERTIS CV, with 8,000 recruits in the study. But they won’t get the final readout until 2019.

Lilly, in the meantime, won an expanded label and boasting rights for Jardiance on the cardiovascular outcomes at the end of 2016, even though it just barely won the expert panel vote after registering a 38% drop in the risk of death. The prospect of an expanded market boosted some estimates of the drug’s potential peak sales to as high as $5 billion or even $6 billion a year. Lilly may never get that far, but the numbers haven’t escaped the attention of Merck and Pfizer, which clearly believe they can compete for a share.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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